The following data is part of a premarket notification filed by Tronomed, Inc. with the FDA for Sterile Extension Tubes Indiv. Pkg..
| Device ID | K792128 |
| 510k Number | K792128 |
| Device Name: | STERILE EXTENSION TUBES INDIV. PKG. |
| Classification | Stopcock, I.v. Set |
| Applicant | TRONOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-24 |
| Decision Date | 1980-01-16 |